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DECISION No. 4819/2004/QD-BYT OF DECEMBER 30, 2004 PROMULGATING THE LIST OF ACTIVE SUBSTANCES AND PREPARATION FORMS OF FOREIGN-MADE MEDICINES, FOR WHICH REGISTRATION OR RE-REGISTRATION DOSSIERS SHALL NOT BE ACCEPTED

THE MINISTER OF HEALTH

Pursuant to the July 11, 1989 Law on Protection of the People’s Health;

Pursuant to the Regulation on Preventive and Curative Medicines, promulgated together with Decree No. 23/HDBT of January 24, 1991 of the Council of Ministers of the Socialist Republic of Vietnam;

Pursuant to the Government’s Decree No. 49/2003/ND-CP of May 15, 2003 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the director of Vietnam Pharmacy Management Department of the Ministry of Health,

DECIDES:

Article 1.- To promulgate the list of 7 active substances and preparation forms of foreign-made medicines, for which registration or re-registration dossiers shall not be accepted (the list is enclosed herewith).

Article 2.- The list prescribed in Article 1 of this Decision shall not apply to medicines containing active substances invented by producers themselves, with relevant papers recognizing the invention.

Article 3.- For medicines containing active substances on the list prescribed in Article 1 of this Decision:

1. For medicines in form of single substance or complex, the registration dossiers shall not be accepted.

2. For medicines in form of new combination of many active substances, if there are documents on clinical tests proving the superiority of therapeutic effects of the complex forms, they shall be regarded as new medicines and their dossiers may be submitted for consideration.

3. For medicines in form of special preparations which cannot be produced in the country such as lyophilized powder to be prepared for injection, effervescent tablet, delayed-action tablet, tablet releasing active substances under control, suppository, and special preparations for children, their dossiers may be submitted for consideration.

Article 4.- This Decision takes effect 15 days after its publication in the Official Gazette and annuls the list of active substances and preparation forms of foreign-made medicines, for which registration or re-registration dossiers shall not be accepted, promulgated together with the Health Minister’s Decision No. 6075/2003/QD-BYT of November 24, 2003.

Article 5.- The director of the Office, the director of Vietnam Pharmacy Management Department, the heads of the Departments, the chief inspector, and the heads of the units, of the Health Ministry; the directors of the provincial/municipal Health Services, the heads of the branch medical organizations and the heads of the concerned units shall have to implement this Decision.

Health Minister
TRAN THI TRUNG CHIEN

LIST OF ACTIVE SUBSTANCES AND PREPARATION FORMS OF FOREIGN-MADE MEDICINES, FOR WHICH REGISTRATION OR RE-REGISTRATION DOSSIERS SHALL NOT BE ACCEPTED

(Promulgated together with the Health Minister’s Decision No. 4819/2004/QD-BYT

of December 30, 2004)

Ordinal number

Name of active substance

Preparation form

1

Amoxicillin

Tablet

2

Ampicillin

Tablet or injection solution

3

Glucose, NaCl of various concentrations

Injection or transfusion solution

4

Cephalexin

Tablet

5

Paracetamol

Tablet

6

Vitamin groups: B1, B6, C

Single-substance tablet: capsule and soft capsule

7

Penicillin of assorted salts

Tablet or injection solution

Health Minister
TRAN THI TRUNG CHIEN